WO2009078010A2 - Enveloppe extravasculaire pour le traitement d'un anévrisme de l'aorte en association avec un stent-greffon endovasculaire et procédés associés - Google Patents

Enveloppe extravasculaire pour le traitement d'un anévrisme de l'aorte en association avec un stent-greffon endovasculaire et procédés associés Download PDF

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Publication number
WO2009078010A2
WO2009078010A2 PCT/IL2008/001621 IL2008001621W WO2009078010A2 WO 2009078010 A2 WO2009078010 A2 WO 2009078010A2 IL 2008001621 W IL2008001621 W IL 2008001621W WO 2009078010 A2 WO2009078010 A2 WO 2009078010A2
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WO
WIPO (PCT)
Prior art keywords
aorta
evw
esg
evr
subject
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PCT/IL2008/001621
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English (en)
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WO2009078010A3 (fr
Inventor
Alon Shalev
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Aneuwrap Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Application filed by Aneuwrap Ltd filed Critical Aneuwrap Ltd
Priority to CA2709278A priority Critical patent/CA2709278A1/fr
Priority to CN200880126889.0A priority patent/CN101965162B/zh
Priority to EP08861980.4A priority patent/EP2231066B1/fr
Priority to US12/808,037 priority patent/US8486131B2/en
Publication of WO2009078010A2 publication Critical patent/WO2009078010A2/fr
Publication of WO2009078010A3 publication Critical patent/WO2009078010A3/fr
Priority to US13/939,798 priority patent/US20130297005A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body

Definitions

  • the present invention generally pertains to an extra-vascular wrapping in the vicinity of the aneurysm neck and specifically the renal arteries for allowing the performance of endovascular aneurysm repair - EVAR - on patients either with aneurysms close to the renal arteries or with type I endoleaks, and methods thereof.
  • An aneurysm is a localized, blood-filled dilation (bulge) of a blood vessel caused by disease or weakening of the vessel wall. Left untreated, the aneurysm will frequently rupture, resulting in loss of blood through the rupture and death.
  • Aneurysms may involve arteries or veins and have various causes. They are commonly further classified by shape, structure and location. Aortic aneurysms are the most common form of arterial aneurysm and are life threatening.
  • the aorta is the main artery which supplies blood to the circulatory system. The aorta arises from the left ventricle of the heart, passes upward and bends over behind the heart, and passes down through the thorax and abdomen. Among other arterial vessels branching off the aorta along its path, the abdominal aorta supplies two side vessels to the kidneys, the renal arteries.
  • the abdominal aorta continues to about the level of the fourth lumbar vertebrae (or the navel), where it divides into the iliac arteries.
  • the iliac arteries supply blood to the lower extremities and perineal region.
  • an aortic aneurysm it is common for an aortic aneurysm to occur in that portion of the abdominal aorta between the renal arteries and the iliac arteries. This portion of the abdominal aorta is particularly susceptible to weakening, resulting in an aortic aneurysm. Such an aneurysm is often located near the iliac arteries. An aortic aneurysm larger than about 5 cm in diameter in this section of the aorta is ominous. Left untreated, the aneurysm may rupture, resulting in rapid, and usually fatal, hemorrhaging. Typically, a surgical procedure is not performed on aneurysms smaller than 5 cm because no statistically demonstrated benefit exists in performing such procedures.
  • Aneurysms in the abdominal aorta are associated with a particularly high mortality rate; accordingly, current medical standards call for urgent operative repair when aneurysm diameter is larger than 5 cm. Abdominal surgery, however, results in substantial stress to the body. Although the mortality rate for an aortic aneurysm is extremely high, there is also considerable mortality and morbidity associated with open surgical intervention to repair an aortic aneurysm. Repair of an aortic aneurysm by surgical means is a major operative procedure. Substantial morbidity accompanies the procedure, resulting in a protracted recovery period. Further, the procedure entails a substantial risk of morbidity and mortality, mostly due to the cardiopulmonary bypass employed in such a procedure.
  • an intraluminal grafting system includes a hollow graft which has a plurality of staples adapted proximate its proximal end.
  • the system includes a guide for positioning the proximal end of the graft upstream in a lumen which may be a blood vessel or artery; and US 5,042,707 which presents a stapler, adapted to be inserted into a blood vessel and moved to a desired position therealong, and having a selectively-articulatable distal marginal end portion used to staple a graft to the interior wall of the blood vessel.
  • an aneurysm when an aneurysm is located near the iliac arteries, there may be an ill-defined neck or no neck below the aneurysm. Such an ill-defined neck would have an insufficient amount of healthy aortic tissue to which to successfully mount a graft. Furthermore, much of the abdominal aorta wall may be calcified which may make it extremely difficult to attach the graft to the wall.
  • Shortcomings of the presently available endovascular stent-graft products include endoleaks, anatomic variability, anatomic non-conformity, migration/ dislocation, discontinuities of endoluminal profile and thrombogenicity.
  • Endoleaks are caused by passage of blood into the aneurismal space subsequent to stent-graft placement.
  • Research has exposed yet another problem which indicates that the necks of the postsurgical aorta increase in size for approximately twelve months, regardless of whether the aneurysm experiences dimensional change. This phenomenon can result in perigraft leaks and graft migration.
  • Anatomic variability although sizing of "tube” or "bifurcated” grafts is radiographically assessed prior to surgery, it is necessary for the surgeon to have a large selection of graft lengths and diameters on hand to ensure an appropriate surgical outcome.
  • Anatomic nonconformity placement of a circularly-profiled graft with an associated fixation device within an essentially "ovoid"-profiled vessel.
  • Migration/dislocation also caused due to the use of attachment means which fasten only to the insubstantial, structurally compromised (diseased) intima and media levels of the vessel wall.
  • Discontinuities of endoluminal profile are potential contributors to hemodynamic disturbances that might lead to non laminar, or even turbulent flow regimen. This in turn can contribute to increased clot formation.
  • Thrombogenicity manufactured of synthetic polymers, contemporary vascular liners present a luminal surface that is typically far more thrombogenic than the native arterial intimal tissue such devices cover
  • Unfavorable anatomy relating to the neck of the aneurysm is the most common reason for patients being rejected for EVAR. Short or absent infrarenal neck, large aortic diameters, and excessive angulation at this level are the main problems.
  • Means and method for repairing aortic aneurysms especially an implementable kit and methods thereof useful for treating an aneurysmatic abdominal aorta, avoiding the dislocation of the implanted kit along the aorta, are still a long felt need.
  • the kit comprises an endovascular stent-graft (ESG) and an extra-vascular wrapping (EVW).
  • ESG comprises a structural member (ESG-SM) adjustable between a radially-expanded state and a radially-compressed state; and, a fluid flow guide (FFG) formed of textile strands, substantially impervious to fluids and adjustable between an expanded state and a radially-compressed state; the FFG including a proximal region along which the fluid flow guide is tubular to provide a primary conduit; the FFG being disposed adjacent to the ESG- SM and being securably attached thereto.
  • ESG-SM structural member
  • FFG fluid flow guide
  • the EVW is having at least one structural member (EVW-SM), e.g., 1,2,4,12, etc, capable of reversibly interchanging between (i) a generally cylindrical expanded state characterized by an inner diameter and a length in the direction of the aorta suitable for surrounding at least an effective portion of the implanted ESG; and (H) a deformed state suitable for laparoscopic delivery of the EVW from a location outside of the subject's body to a location around the aorta, and vice versa.
  • EVW-SM structural member
  • the EVW further comprises at least one medical textile member (e.g., 1,2,4,12 etc) adapted to at least partially encircle a segment of the aneurysmatic aorta in proximity to the renal arteries, the medical textile member being disposed adjacent to the EVW-SM and being securably attached thereto.
  • at least one medical textile member e.g., 1,2,4,12 etc
  • the EVW is adapted by means of size and shape to wrap the aorta in a non-continuous manner.
  • the deformed state of the EVW-SM comprises at least one of the following characteristics: (i) longitudinal deformability, adapted to reduce the length in the direction of the aorta and hence allow insertion of the EVW into a laparoscopic channel; and, (ii) circular-to-linear deformability, adapted to convert the generally cylindrical to a generally linear configuration, so as to provide the EVW to be pushed through a generally straight laparoscopic channel.
  • a secured implantable kit for treating an aneurysmatic abdominal aorta of a human subject comprises at least two attachable elements: an ESG and an EVW.
  • the ESG comprises (i) a structural member (ESG-SM) adjustable between a radially-expanded state and a radially-compressed state; and, (ii) a fluid flow guide (FFG) formed of textile strands, substantially impervious to fluids and adjustable between an expanded state and a radially-compressed state; the FFG including a proximal region along which the fluid flow guide is tubular to provide a primary conduit; the FFG being disposed adjacent to the ESG-
  • ESG-SM structural member
  • FFG fluid flow guide
  • the EVW is having at least one structural member
  • EVW-SM e.g., 1,2,4,12 etc, capable of reversibly interchanging between (i) a generally cylindrical expanded state characterized by an inner diameter and a length in the direction of the aorta suitable for surrounding at least an effective portion of the implanted ESG; and (U) a deformed state suitable for laparoscopic delivery of the EVW from a location outside of the subject's body to a location around the aorta, and vice versa.
  • SM or FFG are in attachment therebetween so that dislocation of the implanted kit along the aorta is avoided
  • attachment comprises reversible attachment.
  • the EVW additionally comprises a plurality of fastening means, adapted to secure the EVW over the aneurysmatic aorta.
  • fastening means are selected from a group consisting of threads, screws, hooks, zips, fasteners, clips, flaps, claspers, springs, claspers, staplers, grips, zippers, hooks and corresponding eyes, hook and loop reclosable fastener squares, hook and loop reclosable fastener strips, hook and loop reclosable fastener dots, hooks-and- loops, e.g., VelcroTM-type fasteners, straps, holes and string, sutures, wires, cables, tabs, poppers, nails, buttons and corresponding button holes, press buttons brackets, glues, adhesives, or any combination thereof.
  • attachment is provided by a means of one or more physical members (e.g. utilizing hooks, pins etc) connecting directly between the ESG and the EVW.
  • EVW-SM and ESG-SM are adapted by means of size and shape to be interlocked therebetween (e.g., providing the elements as two adjacent pieces of a puzzle).
  • the medical textile member of EVW comprises at least one (e.g., 1, 2, 4, 12 etc) internal macroporous layer and at least one (e.g., 1,2,4,12 etc) external microporous layer.
  • the internal macroporous layer is adapted by means of size and shape to be positioned directly over the aneurysmatic abdominal aorta, and comprises voids dimensioned to allow free tissue ingrowth therethrough.
  • the internal macroporous layer is a polymer mesh characterized by a pores ranging in dimension from about 100 ⁇ m to about 2 mm.
  • the external microporous layer is made of a smoothly surfaced material, designed to prevent scar tissue formation and attachment thereto and thereby prevent internal organs from sticking thereto.
  • the external microporous layer is adapted by means of size and shape to be sparsely attached to the internal macroporous layer, so as to allow the free tissue ingrowth while preventing scar tissue formation and attachment to the microporous layer.
  • the means are selected from a group consisting of threads, holes, screws, hooks, zips, fasteners, clips, flaps, claspers, springs, claspers, grips, zippers, hooks-and-loops e.g., VelcroTM-type fasteners, sutures, straps, strings, wires, cables, tabs, poppers, nails, buttons, brackets, glue, adhesives, or any combination thereof.
  • the cylinder is adapted for placement adjacently below renal arteries of the aorta.
  • the EVW in it's the expanded state comprises one or more, complete or partial, interruptions; the cylinder is adapted for placement adjacently above and below renal arteries of the aorta.
  • interruptions in cylinder are adapted to allow passage of the renal arteries.
  • interruptions in cylinder are adapted to allow passage of an inferior mesenteric artery exiting from the aorta.
  • interruptions in cylinder are adapted to allow passage of a celiac artery exiting from the aorta.
  • the EVW-SM is made of a super-elastic metal.
  • the super-elastic metal is Nitinol. It is also in the scope of the invention wherein length of EVW in its the expanded state is in the range between about 1 to 3 centimeters.
  • Another object of the present invention is to disclose an extra-vascular ring (EVR) adapted to at least partially encircle a segment of an aneurysmatic aorta of a human subject in proximity to the renal arteries.
  • the EVR comprises a generally cylindrical inner surface, an outer surface and a structural member; the inner surface and the outer surface are attached therebetween.
  • the fastening means adapted to secure the EVR over the aneurysmatic aorta; EVR is capable of having an expanded state and a deformed state.
  • the EVR in its the expanded state is adapted for extra-vascular positioning around the aorta and the EVR in its deformed state is adapted for laparoscopic delivery from a location outside the subject's body to a location around the aorta;
  • the inner surface defining a lumen that is characterized by a proximal circumference, a distal circumference and a length in the proximal to distal direction;
  • the outer surface is characterized by a proximal circumference, a distal circumference and a length in the proximal to distal direction;
  • the inner surface comprises a macroporous medical textile member, comprises voids dimensioned to allow free tissue ingrowth therethrough, and
  • the outer surface comprises a microporous medical textile member that is made of a smoothly surfaced material, designed to inhibit scar tissue formation and attachment thereto and thereby prevent internal organs from sticking thereto.
  • the structural member connected either to the inner surface or to the outer surface.
  • the EVR further comprises a- plurality of fastening means, e.g., 1, 2, 4, 12, 50 etc.
  • the EVR further comprises a plurality of radially projecting attachment means (e.g., 1, 2, 4, 12 etc).
  • the attachment means being adapted to secure the EVR either to the aorta or to an endovascular aortic stent-graft.
  • the inner surface and the outer surface are radially spaced by a distance in the range between about 2 to 5 millimeters. It is also in the scope of the invention wherein the proximal circumference of outer surface substantially coincides with the proximal circumference of inner surface.
  • distal circumference of outer surface substantially coincides with the distal circumference of inner surface.
  • the structural member is made of a superelastic metal.
  • spacing members are substantially oriented in the radial direction.
  • the method comprises steps selected from the following: (a) identifying a subject having a medical condition indicative of an unacceptably high risk of rupture of an aneurysm of the abdominal aorta; (b) providing an implantable kit as defined in any of the above; (c) introducing the EVW in its the deformed state through a laparoscopic working channel to an abdominal location adjacent to renal arteries of the abdominal aorta; (d) laparoscopically positioning the
  • ESG endovascular stent-graft
  • step (f) comprises attaching
  • the attachable comprises reversibly attachable and wherein the attaching comprises reversibly attaching.
  • the step of identifying a subject having a medical condition indicative of an unacceptably high risk of rupture of an aneurysm of the abdominal aorta comprises identifying a subject having a medical condition indicative of an unacceptably high risk of rupture of an aneurysm of the abdominal aorta and the aneurysm reaching about 2 centimeters or less to a closest renal artery of the subject.
  • the aforesaid method further comprises the steps of (a) upon identification of Type I endoleak - introducing the EVW in a deformed state through a laparoscopic working channel to an abdominal location adjacent to renal arteries of the abdominal aorta of the subject and laparoscopically positioning the EVW around the aorta, in vicinity to renal arteries.
  • the method comprises steps selected from the following: (a) identifying a subject having a medical condition indicative of an unacceptably high risk of rupture of an aneurysm of the abdominal aorta; (b) providing a fastened implantable kit for treating an aneurysmatic abdominal aorta, comprises at least the elements of ESG, EVW, and plurality (e.g., 1,2,4,12,50 etc.) of fastening means, adapted to secure the EVW over the aneurysmatic aorta; (c) introducing the EVW in the deformed state through a laparoscopic working channel to an abdominal location adjacent to renal arteries of the abdominal aorta of the subject; (d) laparoscopically positioning the EVW around the aorta, in vicinity to renal arteries; (e) connecting the corresponding fastening means therebetween; and, (f) endovascularly placing the
  • the method further comprises the steps of (a) upon identification of Type I endoleak - introducing the EVW in a deformed state through a laparoscopic working channel to an abdominal location adjacent to renal arteries of the abdominal aorta of the subject and laparoscopically positioning the EVW around the aorta, in vicinity to renal arteries and connecting the corresponding fastening means to one another.
  • FIGS. IA to ID depict different variants of fasteners according to few embodiments of the invention
  • FIG. 2 depicts an EVR according to another embodiment of the invention
  • FIG. 3 depicts an EVR according to yet another embodiment of the invention
  • FIG. 4 depicts an EVR according to yet another embodiment of the invention.
  • FIG. 5 depicts an EVR according to yet another embodiment of the invention.
  • FIG. 6 depicts an EVR according to yet another embodiment of the invention.
  • FIG. 7 depicts an EVR according to yet another embodiment of the invention.
  • FIG. 8A depicts an extra-vascular wrapping (135), which include a structural member (140) and a medical textile member (141);
  • FIG. 8B depicts an abdominal aorta (130), a right renal artery (131), a left renal artery (132), over which the extra-vascular wrapping (135) of figure 8a is positioned, adjacently below the renal arteries (131, 132) and is adapted to allow renal arteries (131, 132) to exit thereabove;
  • FIG. 9A depicts an isometric view of the structural member of the extra vascular wrapping
  • FIG. 9B depicts an axial view of the structural member of the extra vascular wrapping
  • FIG. 9C depicts a side view of the structural member of the extra vascular wrapping.
  • FIG. 9D depicts a view of a circularly-to-linearly deformed structural member of the extra vascular wrapping.
  • FIG. 9E depicts a view of a circularly-to-linearly deformed and a longitudinally deformed structural member of the extra vascular wrapping.
  • an implementable kit for treating an aneurysmatic abdominal aorta comprises at least two attachable elements: an endovascular stent-graft (ESG) and an extra-vascular wrapping (EVW).
  • ESG comprises a structural member (ESG-SM) adjustable between an expanded state and a radially-deformed state; and a fluid flow guide (FFG) formed of textile strands, substantially impervious to fluids and adjustable between an expanded state and a radially-deformed state; the FFG including a proximal region along which the fluid flow guide is tubular to provide a primary conduit.
  • ESG endovascular stent-graft
  • EVW extra-vascular wrapping
  • the ESG comprises a structural member (ESG-SM) adjustable between an expanded state and a radially-deformed state; and a fluid flow guide (FFG) formed of textile strands, substantially impervious to fluids and adjustable between an expanded state and a radially-deformed state; the FFG including a proximal
  • the EVW comprises an extra-vascular wrapping (EVW), the EVW having at least one (e.g., 1,2,4,12 etc) structural member (EVW-SM), capable of reversibly interchanging between (i) an expanded state characterized by an inner diameter and a length in the direction of the aorta suitable for surrounding at least an effective portion of the implanted ESG; and (U) a deformed state suitable for laparoscopic delivery to a location around the aorta, and vice versa.
  • the EVW-SM and either the ESG-SM or FFG are at least reversibly attachable in a manner that a dislocation of the implanted kit along the aorta is avoided.
  • the aforesaid EVW additionally comprises a plurality (e.g., 1, 2, 4, 12, 50 etc) of fastening means, adapted to secure the EVW over the aneurysmatic aorta.
  • the fastening means are selected in a non-limiting manner from a group consisting of threads, screws, hooks, zips, fasteners, clips, flaps, claspers, springs, claspers, staplers, grips, zippers, hooks and corresponding eyes, hook and loop reclosable fastener squares, hook and loop reclosable fastener strips, hook and loop reclosable fastener dots, hooks-and-loops, e.g., VelcroTM-type fasteners, straps, holes and string, wires, cables, tabs, poppers, nails, buttons and corresponding button holes, press buttons brackets, glues, adhesives, or any combination thereof.
  • endoleak refers to Type I Endoleak, which comprises a failure to seal attachment sites of an endovascular stent-graft to the native vessels. This is widely recognized as the type of endoleak that is most closely linked to rupture and is therefore the most aggressively treated
  • EVR extra-vascular ring
  • the EVR is adapted to at least partially encircle a segment of an aneurysmatic aorta in proximity to the renal arteries.
  • the EVR comprises a substantially tubular inner surface, an outer surface and a plurality of fastening means; the inner surface and the outer surface are attached thereto; the fastening means adapted to secure the EVR over the aneurysmatic aorta.
  • the EVR is capable of having an expanded state and a deformed state.
  • the EVR in its the expanded state is adapted for extra-vascular positioning around an aorta and the EVR in its the deformed state is adapted for laparoscopic delivery to a location around the aorta.
  • the inner surface defining a lumen that is characterized by a proximal circumference, a distal circumference and a length in the proximal to distal direction; the outer surface is characterized by a proximal circumference, a distal circumference and a length in the proximal to distal direction.
  • the inner surface may comprises (i) a macroporous medical textile member, comprises voids dimensioned to allow free tissue ingrowth therethrough, and (ii) a structural member connected thereto.
  • the outer surface may comprises (i) a microporous medical textile member that is made of a smoothly surfaced material, designed to prevent scar tissue formation and attachment thereto and thereby prevent internal organs from sticking thereto and (ii) a structural member disposed therein and attached thereto.
  • Still another embodiment of the invention wherein method for treating an aneurysmatic aorta.
  • the method comprises steps selected from the following: (a) identifying a subject having a medical condition indicative of an unacceptably high risk of rupture of an aneurysm of the abdominal aorta; (b) obtaining an implementable kit as defined in any of the above; (c) introducing the EVW in a deformed state through a laparoscopic working channel to an abdominal location adjacent to renal arteries of the abdominal aorta of the subject; (d) laparoscopically positioning the EVW around the aorta, in vicinity to renal arteries; (e) introducing a healing period of no less than 1 week; (f) endovascularly placing the Endovascular stent-graft (ESG) into the aneurysmatic aorta in the subject; and (g) at least reversibly detaching the EVW-SM and either the ESG-SM or FFG in a manner that a dislocation of
  • a further embodiment of the invention wherein another method for treating an aneurysmatic aorta comprises steps selected from the following: (a) identifying a subject having a medical condition indicative of an unacceptably high risk of rupture of an aneurysm of the abdominal aorta; (b) obtaining a fastened implementable kit for treating an aneurysmatic abdominal aorta, as defined above, namely a kit comprises a plurality of fastening means, adapted to secure the EVW over the aneurysmatic aorta; (c) introducing the EVW in a deformed state through a laparoscopic working channel to an abdominal location adjacent to renal arteries of the abdominal aorta of the subject; (d) laparoscopically positioning the EVW around the aorta, in vicinity to renal arteries; (e) connecting the corresponding fastening means to one another; (f) introducing a healing period of no less than 1 week; (g) endovascularly placing the ESG
  • FIGS. IA to ID depict different variants of fasteners: hooks and loops reclosable fastener stripes (e.g. hooks) and hatched stripes denote the complementary (e.g. loops) type of hooks and loops reclosable fastener stripes;
  • FIG. 2 depicts an Extra Vascular Ring wherein the inner surface (10) and the outer surface (11) are concentrically aligned and are radially spaced by a substantially constant distance.
  • FIG. 3 depicts an Extra Vascular Ring comprising an inner surface (20) and an outer surface
  • FIG. 4 depicts an abdominal aorta (100), a right renal artery (101), a left renal artery (102), a celiac artery (103) and an inferior mesenteric artery (104).
  • An extra-vascular wrapping (105) is positioned adjacently below the renal arteries.
  • FIG. 5 depicts an abdominal aorta (110), a right renal artery (111), a left renal artery (112), a celiac artery (113) and an inferior mesenteric artery (114). Further depicted is an extra-vascular wrapping having a distal section (115) that is positioned adjacently below the renal arteries (111,
  • a proximal section (117) that is positioned adjacently below the renal arteries (111,
  • a bridging section (116) that connects between the distal section (115) and the proximal section (117).
  • FIG. 6 depicts an abdominal aorta (120), a right renal artery (121), a left renal artery (122), a celiac artery (123) and an inferior mesenteric artery (124).
  • An extra-vascular wrapping (125) is positioned adjacently below the renal arteries and is adapted to allow renal arteries (121, 122) to exit through a substantially side-looking recesses in extra-vascular wrapping (125).
  • FIG. 7 depicts an abdominal aorta (130), a right renal artery (131), a left renal artery (132), a celiac artery (133) and an inferior mesenteric artery (134).
  • An extra-vascular wrapping (135) is positioned adjacently below the renal arteries (131, 132) and is adapted to allow renal arteries (131, 132) to exit through a substantially side-looking recesses in extra-vascular wrapping (135).
  • the extra-vascular wrapping (135) further allows the celiac artery (133) and the inferior mesenteric artery (134) to exit through a substantially forward-looking recess.
  • FIG. 8A depicts an extra-vascular wrapping (135), which include a structural member (140) and a medical textile member (141).
  • FIG. 8B depicts an abdominal aorta (130), a right renal artery (131), a left renal artery (132), over which the extra-vascular wrapping (135) of figure 8a is positioned, adjacently below the renal arteries (131, 132) and is adapted to allow renal arteries (131, 132) to exit thereabove.
  • FIG. 9A depicts an isometric view of the structural member of the extra vascular wrapping.
  • FIG. 9B depicts an axial view of the structural member of the extra vascular wrapping.
  • FIG. 9c depicts a side view of the structural member of the extra vascular wrapping.
  • FIG. 9D depicts a view of a circularly-to-linearly deformed structural member of the extra vascular wrapping.
  • FIG. 9E depicts a view of a circularly-to-linearly deformed and a longitudinally deformed structural member of the extra vascular wrapping, so that it facilitates insertion of the extra vascular wrapping into a laparoscopic channel.

Abstract

L'invention concerne un système de traitement d'un anévrisme abdominal de l'aorte, comprenant (a) une enveloppe extravasculaire (EVW) qui comporte (i) au moins un élément textile médical conçu pour encercler au moins en partie un segment de l'aorte à proximité des artères rénales et (ii) un élément structurel, l'EVW étant conçue pour être placée par laparoscopie, et (b) un stent-greffon endovasculaire (ESG) comprenant (i) un élément structurel compressible auquel est relié (ii) un guide d'écoulement de fluide (FFG) essentiellement imperméable aux fluides. L'invention concerne également un anneau extravasculaire (EVR) conçu pour encercler le col de l'anévrisme de l'aorte. L'invention concerne en outre des procédés de traitement d'un anévrisme abdominal de l'aorte, comprenant le placement par laparoscopie de l'enveloppe extravasculaire (EVW) et le placement endovasculaire du stent-greffon endovasculaire (ESG). L'invention concerne également des procédés de traitement d'une hémorragie interne de type I.
PCT/IL2008/001621 2007-12-15 2008-12-15 Enveloppe extravasculaire pour le traitement d'un anévrisme de l'aorte en association avec un stent-greffon endovasculaire et procédés associés WO2009078010A2 (fr)

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CA2709278A CA2709278A1 (fr) 2007-12-15 2008-12-15 Enveloppe extravasculaire pour le traitement d'un anevrisme de l'aorte en association avec un stent-greffon endovasculaire et procedes associes
CN200880126889.0A CN101965162B (zh) 2007-12-15 2008-12-15 用于与血管内支架-移植物联用治疗主动脉瘤的血管外包套及其方法
EP08861980.4A EP2231066B1 (fr) 2007-12-15 2008-12-15 Enveloppe extravasculaire pour le traitement d'un anévrisme de l'aorte en association avec un stent-greffon endovasculaire
US12/808,037 US8486131B2 (en) 2007-12-15 2008-12-15 Extra-vascular wrapping for treating aneurysmatic aorta in conjunction with endovascular stent-graft and methods thereof
US13/939,798 US20130297005A1 (en) 2007-12-15 2013-07-11 Extra-vascular wrapping for treating endoleak

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US1403107P 2007-12-15 2007-12-15
US61/014,031 2007-12-15

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US12/808,037 A-371-Of-International US8486131B2 (en) 2007-12-15 2008-12-15 Extra-vascular wrapping for treating aneurysmatic aorta in conjunction with endovascular stent-graft and methods thereof
US13/939,798 Continuation US20130297005A1 (en) 2007-12-15 2013-07-11 Extra-vascular wrapping for treating endoleak

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WO2009078010A3 WO2009078010A3 (fr) 2010-03-11

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EP2231066A2 (fr) 2010-09-29
US20130297005A1 (en) 2013-11-07
EP2231066A4 (fr) 2015-04-22
CA2709278A1 (fr) 2009-06-25
CN101965162B (zh) 2014-12-10
WO2009078010A3 (fr) 2010-03-11
US20100292774A1 (en) 2010-11-18
EP2231066B1 (fr) 2017-04-26
CN101965162A (zh) 2011-02-02

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